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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA011160 | U.S. NIH Grant/Contract | View source | |
| R01-11160-1 |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
The purpose of this study is to assess the clinical efficacy of the buprenorphine/naloxone combination tablet for alternate-day dosing and determine whether multiples of the daily dose are necessary to maintain an effective alternate day dosing regimen.
Alternate-day dosing with the 8mg buprenorphine-naloxone tablet is as safe and effective as daily dosing. Outcomes are improved when the total weekly dose provided during alternate-day dosing is equal to that given during daily dosing.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heroin Dependence | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Drug use | ||
| Retention | ||
| Subjective dose estimate | ||
| Observed withdrawal rating | ||
| Opioid agonist rating | ||
| Opioid antagonist rating | ||
| Pupil diameter | ||
| Compliance | ||
| Analog rating scale for drug effects | ||
| Drug effect characteristics | ||
| Dose order estimate-nurse | ||
| Dose order estimate-client |
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Inclusion Criteria:
Individuals must be currently opioid dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency.
Exclusion Criteria:
Individuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.
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| Name | Affiliation | Role |
|---|---|---|
| Leslie Amass, Ph.D. | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Health Sciences Center | Denver | Colorado | 80206 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | (presented at ACNP 1997. Kamien, J.B., Mikulich, S.K., and Amass, L., Efficacy of the buprenorphine/naloxone tablet for daily vs. alternate-day opioid dependence treatment. Presented to the 1998 Meeting of the College on Problems of Drug Dependence.. Presented at ACNP 1997 and CPDD 1998. |
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| ID | Term |
|---|---|
| D006556 | Heroin Dependence |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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